Main purpose of the job: To provide leadership of key functions in the Isango Lethemba Research Unit department, through cross-functional liaison and effective management of resources and processes, quality and stakeholder engagement Location: Jose Pearson TB Hospital, Gqeberha (Port Elizabeth) Key performance areas: The function includes oversight of processes, workflows, and procedures, overseeing the quality assurance, ethics and regulatory processes, data, and administrative processes report for ongoing projects Assist in inventory, procurement, and stock in the clinic Lead the clinic team to ensure that all clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, and organization goals: provide guidance, project-planning, resource management, scheduling and delegating responsibilities and assignments appropriately, and monitoring and driving study objectives Maintain channels of effective communication and conduct regular department and study-related meetings with investigators, coordinators, research staff, and unit leadership as required to ensure departmental communication and efficiency Oversee the development, implementation, and enforcement of policies, procedures, operational systems, and other processes within the clinic Troubleshoot daily clinic operational issues in collaboration with the clinical operations team Review status reports of applicable projects and project teams and address issues accordingly Provide comprehensive support of all operational aspects of clinical trials including overall delivery of protocol objectives, logistics, visit scheduling including home visits, administration, reporting, and data collection Review status reports of applicable projects and project teams and address issues accordingly Ensure research teams maintain protocol integrity throughout the study Support investigators and other departments as needed in generating source documents, designing and reviewing protocol-specific forms and study-related documents Liaise with other departments as required to ensure study deliverables are met and processes effective Monitor all study progress ensuring compliance with relevant regulations, guidelines, protocols Regularly review monitoring reports and data quality Identify potential issues and solutions Identify quality improvement areas and implement and measure related initiatives in collaboration with the clinic operations manager Oversee maintenance and deployment/use of study documents and files (e.g. regulatory files/Investigator Site Files, work instructions/SOPs, CRFs, and related guidelines, etc.) in collaboration with the clinic operations manager Enforce organizational standard operating procedures in all operations as well as ethical guidelines and principles of Good Clinical Practice Ensure compliance with all internal and external relevant policies Support the development of the department including long-term strategy and research agenda; set and drive strategic plan reporting on quarterly and annual indicators Pursue own research interests consistent with the overall research agenda of the organization and in conjunction with the research leadership team Advise on the implementation of large multi-site research and dynamically contribute to new, relevant research questions Identify and pursue new funding opportunities in line with the organization's interest and own research goals Manage internal and external stakeholder expectations and communicate appropriately with initiative and solutions Build and maintain a high standard of professional, authentic internal and external stakeholder relationships (internal relations at all levels of the organization, and external relations with relevant public, private, and third sector stakeholders as well as academic collaborators and media where applicable) Demonstrate integrated and effective problem-solving and apply discretion and diplomacy as required Support program-specific communications and participate in organizational communications, driving organizational values Lead cross-functional, multi-disciplinary teams to promote productivity within projects; effectively supervise and manage staff duties and targets, and maintain sound labor relations Coordinate and conduct training on the requirements for specific studies/program components and ensure robust regular review and ongoing development of team capabilities Work with management to empower and develop teams or individuals as skills needs or deficiencies are identified Foster an environment that promotes talent recognition, development as well as agency and individual leadership; promote harmony, teamwork, and sharing of information Contribute towards the development of team/company knowledge by identifying relevant training needs and topics Develop and deliver relevant training material and presentations and contribute to internal knowledge sharing in areas of expertise Conduct ad hoc research training interventions i.e., Journal Clubs, Writing Series, Research Methodology Course Apply knowledge of the organizational systems, structures, policies, and procedures to achieve results Work with management to empower and develop teams or individuals as skills needs or deficiencies are identified Take ownership and accountability for responsibility areas, demonstrate effective self-management, demonstrate team and individual leadership and collaboration to support everyone's combined and individual objectives Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained Support and drive the business's core values Maintain a positive attitude and respond openly to feedback Required minimum education and training: MBBCh or MBCHB or Relevant postgraduate Degree or Equivalent Required minimum work experience and abilities: 5 years experience in clinical trials Professional body registration: HPCSA Desirable additional education, work experience, and personal abilities: Communicate and maintain effective working relationships with all staff at various levels Demonstrable experience with training, quality assurance, regulatory affairs, trial management, and CRO liaison TO APPLY: Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV. Please Apply Online. Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position. The closing date for all applications: 18 July 2024. Note AJ Personnel is fully POPI compliant. Note WHC, in accordance with their Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto. Please note: AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium. Wits Health Consortium will only respond to shortlisted candidates. Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful. AJ Personnel does not have any salary or other information regarding the position.
